NCT05241288

Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

Use of ProAir Digihaler in Chronic Obstructive Pulmonary Disease (COPD) - Characterization of Inhalation Metrics From a Cohort of Patient At-risk for Acute Exacerbation of COPD (AECOPD) in an Outpatient Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center 3-month study to determine the variation in ProAir Digihaler metrics \[peak inspiratory flow (PIF), inhalation volume, number of inhalation events\] amongst COPD patients in the ambulatory setting.

Detailed description

The albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) (ProAir® Digihaler®) is the first and only Food and Drug Administration (FDA) approved inhaler rescue medication with a built-in sensor to detect and record inhaler use. The inhaler device measures PIF and the app groups PIF into categories that can help to highlight potential patient inhaler technique errors. This study will deploy this product in COPD patients to establish foundational data on Digihaler metrics in a COPD population at greater risk for COPD exacerbations. Adult subjects with COPD recruited from two sites \[University of North Carolina (UNC) and Wake Forest\] will participate in a longitudinal study to collect data regarding the normal variation in Digihaler metrics (PIF, inhalation volume, number of inhalations), a daily self-assessment asking "How are you feeling?" with responses provided on a Likert scale as well as responses to a Digihaler metric algorithm-triggered digital automated questionnaire (DAQ) in a stable COPD population with history of an AECOPD, to assess correlations of Digihaler metrics to daily self-assessment and DAQ responses, correlations of self-reported to actual short acting beta agonist (SABA) use and symptoms, and the changes in inhaler parameters and SABA use around incidental AECOPD.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Albuterol eMDPI DS	Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 3 component devices: Device 1: Albuterol eMDPI Device 2: Albuterol eMDPI Patient-facing smart device application (App) Device 3: Digital Health Platform (DHP, Cloud solution)

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-02-13
• Completion: 2023-02-13
• First posted: 2022-02-15
• Last updated: 2024-01-23
• Results posted: 2024-01-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study